Trial Outcomes & Findings for Ankle - Brachial Index Measurement in Atrial Fibrillation (NCT NCT02986282)

Last Updated: 2017-07-18

Results Overview

3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

Through the study

Results posted on

2017-07-18

Participant Flow

One hundred and fifteen consecutive patients with atrial fibrillation admitted to Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw for electrical cardioversion were screened. Participants were recruited to the study from October 2012 up to December 2015.

Participant milestones

Participant milestones
Measure	Single Arm Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation ABI measurement using both doppler and oscillometric method
Overall Study STARTED	115
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ankle - Brachial Index Measurement in Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=99 Participants Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation ABI measurement using both doppler and oscillometric method.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	61 Participants n=5 Participants
Age, Continuous	66.5 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Poland	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Through the study

Outcome measures

Outcome measures
Measure	Single Arm n=99 Participants Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation ABI measurement using both doppler and oscillometric method
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). ABI doppler after	1.18 ratio Interval 1.09 to 1.25
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). ABI oscillometric before	1.21 ratio Interval 1.13 to 1.27
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). ABI oscillometric after	1.215 ratio Interval 1.14 to 1.26
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). ABI doppler before	1.14 ratio Interval 1.07 to 1.2175

SECONDARY outcome

Timeframe: Through the study period

3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants

Outcome measures

Outcome measures
Measure	Single Arm n=99 Participants Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation ABI measurement using both doppler and oscillometric method
Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method. ABI doppler before	1.14 ratio Interval 1.07 to 1.2175
Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method. ABI doppler after	1.18 ratio Interval 1.09 to 1.25

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jacek Lewandowski

Warsaw Medical University

Phone: 5992828

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place